Collection and Characterisation of Human Olfactory Ensheathing Cells
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Ability to culture olfactory ensheathing cells from human donors
研究概览
简要总结
We aim to retrieve olfactory bulbs (OBs) from suitable human donors. We have defined two groups who will qualify:
Group 1 - Deceased Donors:
1A: Donors after brainstem death (DBDs) undergoing solid organ donation
1B: Donors after brainstem death (DBDs) considered unsuitable for solid organ donation
Group 2 - Living Donors:
Neurosurgical patients undergoing anterior cranial surgery in which the olfactory nerve (ON) is cut as part of the surgical procedure. The OB of the concomitant severed ON would be donated.
We aim to optimise OB collection and Olfactory Ensheathing Cell (OEC) culture and storage. We will study the effects of patient diagnosis, age, cause of death (if applicable), co-morbidities and warm ischaemic time on cell survival and regenerative function.
In future studies we aim to store OECs in a GMP facility and transplant OECs into patients with spinal cord injuries.
详细描述
Spinal cord injury (SCI) is a devastating condition. To date there is no treatment to improve outcome. There is limited regenerative capacity of the central nervous system (CNS), such that damaged neurons and severed axons are not replaced.
A substantial body of evidence suggests that olfactory ensheathing cells (OECs) obtained from olfactory bulbs (OBs) facilitate neuronal regeneration in rodents and humans with SCI. Indeed, transplanting autologous OECs from an OB into the injury site improved neurological outcome in a patient with SCI.
Harvesting autologous OBs to culture OECs has several disadvantages:
- If the OECs do not grow in vitro, the transplantation is abandoned;
- The retrieval procedure exposes a paralysed patient to the risks of craniotomy;
- Excising an OB can impair the sense of smell; and
- The number of OECs obtained is limited to one OB.
Investigators will collect human OECs from suitable donors which we have defined as two groups. Group 1 patients will be brain dead donors identified by the neuro-intensive care team as potential candidates for solid organ donation. The OBs will be retrieved as near to death as possible. Group 2 patients will be living donors undergoing elective neurosurgery in which the olfactory nerve is sacrificed as part of that procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Ability to culture olfactory ensheathing cells from human donors
时间窗: 10-15 days
Number of olfactory ensheathing cells cultured per olfactory bulb at days 10-15 in vitro.
次要结局
- Effect of cause of death for Group 1 donors(10-15 days)
- Effect of freeze/thaw cycles(10-15 days)
- Effect of time from extraction to culture at 4 deg C(1 month)
- Effect of patient age(10-15 days)
- Effect of storage in liquid nitrogen(up to 1 month)
- Effect of time from extraction to culture at room temperature(1 month)